Table of Contents
- ABOUT HEALTHCARE
- About the cardiovascular pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the heart failure disease market
- Key metrics
- Datamonitor Pipeline Assessment Summary
- Related reports
- CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
- Heart failure: a diverse pipeline
- Greatest number of candidates in Phase II of development
- High attrition rate within the pipeline
- Market not dominated by one company
- Key R&D company strategies
- Expanded indications for approved drugs
- Niche patient subgroups
- CHAPTER 3 HEART FAILURE OVERVIEW - MARKET POTENTIAL
- Definition of Heart Failure
- Acute heart failure
- Chronic heart failure
- Etiology of heart failure
- Segmentation of heart failure
- Disease severity
- Low versus high output failure
- Systolic versus diastolic heart failure
- Age group
- Co-morbidities, complications and risk factors
- Anemia: an emerging risk factor in chronic heart failure
- Erythropoietin in the treatment of anemia in chronic heart failure
- Devices and surgery: treatments for end-point heart failure
- Cardiac devices
- Cardiac resynchronization therapy (CRT)
- Implantable cardioverter defibrillators (ICD)
- Ventricular Assist Devices (VAD)
- Total artificial heart
- Novel devices under development
- Surgery
- Telemedicine (Disease management)
- Epidemiology of heart failure
- Future incidence of acute heart failure
- Future prevalence of chronic heart failure
- Future trends in the incidence and prevalence of heart failure
- Unmet need in heart failure
- Acute heart failure
- Unmet need 1: increased efficacy
- Unmet need 2: drugs with novel mechanisms of action
- Unmet need 3: reduced length of hospital stay/ re-hospitalization
- Unmet need 4: improved safety profile
- Unmet need 5: increased mortality benefit
- Chronic heart failure
- Unmet need 1: targeting niche markets
- Unmet need 2: increased efficacy
- Unmet need 3: increased compliance
- Unmet need 4: increased safety profile
- Unmet need 5: ability to halt or reverse the progression of the
disease
- Unmet need 6: drugs with novel mechanisms of action
- CHAPTER 4 R&D APPROACH
- Classification of pipeline products
- Acute heart failure
- Potassium channel activator/nitric oxide donor
- Vasopressin V2 antagonists
- Preclinical and clinical progress
- Adenosine A1 antagonists
- Preclinical and clinical progress
- Atrial natriuretic peptide (ANP) agonists
- Preclinical and clinical progress
- Endothelin ET-A antagonists
- Preclinical and clinical progress
- Cardiac myosin activators
- Preclinical and clinical progress
- CRF-R2 agonists
- Preclinical and clinical progress
- Na+/K+ ATPase inhibitors
- Preclinical and clinical progress
- ORL-1 agonists
- Preclinical and clinical progress
- Soluble guanylate cyclase modulators
- Preclinical and clinical progress
- Chronic heart failure
- Angiotensin II antagonists
- Adenosine A1 antagonists
- Preclinical and clinical progress
- Renin inhibitors
- Preclinical and clinical progress
- HMG CoA reductase inhibitors (statins)
- Preclinical and clinical progress
- Immunotherapy
- Preclinical and clinical progress
- Chelating agents
- Preclinical and clinical progress
- Brain natriuretic protein (BNP) agonists
- Preclinical and clinical progress
- Dual NEP/ECE inhibitors
- Preclinical and clinical progress
- Sino-atrial node inhibitors
- Preclinical and clinical progress
- Endothelial nitric oxide synthase (eNOS) transcription enhancer
- Preclinical and clinical progress
- Chymase inhibitors
- Preclinical and clinical progress
- AGE crosslink breakers
- Preclinical and clinical progress
- Undefined heart failure
- Myoblast cell therapy
- Preclinical and clinical progress
- PPARa agonists
- Preclinical and clinical progress
- Relaxin agonists
- Preclinical and clinical progress
- SERCA 2a gene therapy
- Preclinical and clinical progress
- CGRP agonists
- Preclinical and clinical progress
- Clinical trial design in heart failure
- Comparators: add-on versus replacement therapy
- Clinical trials endpoints in heart failure
- Use of surrogate endpoints
- Trials in acute heart failure
- True endpoints
- Surrogate endpoints
- Trials in chronic heart failure
- True endpoints
- Surrogate endpoints
- CHAPTER 5 ACUTE HEART FAILURE LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for acute heart failure
- Pipeline summary
- Comparative forecasts
- Definition of current comparator therapy
- Oral diuretics
- Nitrates
- Inotropic agents
- Vasodilators
- Tolvaptan
- Drug overview
- Clinical data
- Completed trials
- EVEREST
- SALT-1 and SALT-2
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- SWOT analysis
- Forecasts to 2016
- Datamonitor drug assessment summary
- Ularitide (urodilatin)
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- SWOT analysis
- Forecasts to 2016
- Datamonitor drug assessment summary
- KW-3902
- Drug overview
- Ongoing clinical trials
- REACH UP
- PROTECT-1 and PROTECT-2
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- SWOT analysis
- Forecasts to 2016
- Datamonitor drug assessment summary
- Other drugs in acute heart failure
- CK-1827452 (CK-452)
- Drug profile
- Clinical data
- Sitaxentan (Thelin)
- Restarting of clinical trials
- Urocortin II
- Drug profile
- Clinical data
- Istaroxime (PST-2744)
- Drug profile
- Clinical data
- ZP-120
- Innovative early-stage projects
- TBC-3711
- Drug overview
- Preclinical data
- BAY-58-2667
- Drug overview
- Preclinical development
- Late-stage development compounds recently discontinued
- Levosimendan (Simdax)
- Carperitide (HANP)
- CHAPTER 6 CHRONIC HEART FAILURE LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Overview for chronic heart failure
- Pipeline summary
- Comparative forecasts
- Definition of comparator therapy
- Chronic heart failure ' gold standard'
- Irbesartan (Aprovel)
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- SWOT analysis
- Forecasts to 2016
- Datamonitor drug assessment summary
- Aliskiren (Tekturna)
- Drug overview
- Ongoing clinical trials
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- SWOT analysis
- Forecasts to 2016
- Datamonitor drug assessment summary
- Rosuvastatin (Crestor)
- Drug overview
- Ongoing clinical trials
- CORONA
- NCT00176332
- GISSI-HF
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- SWOT analysis
- Forecasts to 2016
- Datamonitor drug assessment summary
- Celacade (VAS-991)
- Drug overview
- Clinical data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- SWOT analysis
- Forecasts to 2016
- Datamonitor drug assessment summary
- Other drugs in chronic heart failure
- Trientine
- Drug overview
- Clinical data
- CG-77X56 (Cardeva)
- Daglutril
- Drug overview
- Clinical data
- BG-9928
- Drug overview
- Clinical data
- SLV-320
- Ivabradine
- Alagebrium chloride (ALT-711)
- Drug overview
- Clinical trials restart
- Innovative early-stage projects
- AVE-3085 and AVE-9488
- Drug overview
- Preclinical data
- TPC-806
- Drug overview
- Preclinical data
- Renin inhibitors
- Late-stage development compounds recently discontinued
- Oxypurinol
- rGLP-1
- DITPA
- SSR-180575
- CHAPTER 7 UNDEFINED HEART FAILURE LATE-STAGE DRUG ANALYSIS
- Nicorandil
- Drug overview
- Clinical data
- Myocell
- Drug overview
- Clinical data
- Other drugs in undefined heart failure
- Innovative early-stage projects
- CHAPTER 8 BIBLIOGRAPHY
- Epidemiology sources
- General and clinical trial data
- APPENDIX A
- Methodology
- Epidemiology
- Incidence of acute heart failure
- Prevalence of chronic heart failure
- Datamonitor drug assessment summary
- Appendix B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare' s therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: Incidence and prevalance of Heart Failure for the seven major
markets
- Table 2: Forecast key pipeline products in Acute Heart Failure in 2016
($m)
- Table 3: Forecast key pipeline products in Chronic Heart Failure in
2016 ($m)
- Table 4: R&D pipeline in the acute heart failure market, 2007
- Table 5: R&D pipeline in the chronic heart failure market, 2007
- Table 6: R&D pipeline in the undefined heart failure market, 2007
- Table 7: Heart failure pipeline by mechanism of action, 2007
- Table 8: Heart failure pipeline by company, 2007
- Table 9: Causes of heart failure in the seven major markets (%), 2004
- Table 10: Prevalence of chronic heart failure by age group in the
seven major markets (000s), 2005
- Table 11: Estimated proportion of chronic heart failure patients with
co-morbid conditions and risk factors in the seven major markets (%), 2004
- Table 12: Future estimated incidence of acute heart failure in the
seven major markets (000s), 2007-2016
- Table 13: Future estimated incidence of chronic heart failure in the
seven major markets (000s), 2007-2016
- Figure 11: Unmet needs in acute heart failure, 2007
- Table 14: Key products in late-stage R&D pipeline for acute heart
failure, 2007
- Table 15: Sales forecasts for late-stage acute heart failure pipeline
drugsacross the seven major markets, 2007-2016
- Table 16: Discontinued R&D projects in acute heart failure, 2005-07
- Table 17: Key agents in late-stage R&D pipeline for chronic heart
failure, 2007
- Table 18: Datamonitor forecasts for late-stage chronic heart failure
pipeline drugs across the seven major markets, 2007-2016
- Table 19: Datamonitor drug assessment parameters
- List of Figures
- Figure 1: Datamonitor drug assessment summary of pipeline therapies in
development for acute heart failure, 2007
- Figure 2: Datamonitor drug assessment summary of pipeline therapies in
development for chronic heart failure, 2007
- Figure 3: Candidates in development for heart failure by indication
- Figure 4: Overview of heart failure pipeline, 2007
- Figure 5: Percentage of heart failure R&D products in development,
2007
- Figure 6: Heart failure pipeline development by company type, 2007
- Figure 7: Geographical location of companies with agents in
development for heart failure pipeline, 2007
- Figure 8: Segmentation of diagnosed chronic heart failure patients by
disease severity, 2004
- Figure 9: ACC/AHA practice guidelines for the evaluation and
management of chronic heart failure, 2005
- Figure 10: Breakdown of heart failure patients according to whether
failure is systolic, diastolic or both systolic and diastolic in the seven
major markets, 2004
- Figure 12: Unmet needs in chronic heart failure, 2007
- Figure 13: Key mechanisms of disease progression in Heart Failure
- Figure 14: Datamonitor drug assessment summary of pipeline therapies
in development for acute heart failure, 2007
- Figure 15: Datamonitor forecasts for late-stage acute heart failure
pipeline drugs across the seven major markets, 2007-2016
- Figure 16: SWOT analysis: tolvaptan
- Figure 17: Datamonitor forecast for tolvaptan in acute heart failure
across the seven major markets, 2007-2016
- Figure 18: Datamonitor' s competitive positioning analysis of
Tolvaptan, 2007
- Figure 19: SWOT analysis: ularitide
- Figure 20: Datamonitor' s forecast for ularitide in acute heart failure
across the seven major markets, 2007-2016
- Figure 21: Datamonitor' s competitive positioning analysis of
ularitide, 2007
- Figure 22: SWOT analysis: KW-3902
- Figure 23: Datamonitor' s forecast for KW-3902 in acute heart failure
across the seven major markets, 2007-2016
- Figure 24: Datamonitor' s competitive positioning analysis of KW-3902,
2007
- Figure 25: Datamonitor drug assessment summary of pipeline therapies
in development for chronic heart failure, 2007
- Figure 26: Datamonitor' s forecasts for late-stage chronic heart
failure pipeline drugs across the seven major markets , 2007-2016
- Figure 27: SWOT analysis: irbesartan
- Figure 28: Datamonitor' s forecast for irbesartan in chronic heart
failure across the seven major markets, 2007-2016
- Figure 29: Datamonitor' s competitive positioning analysis of
Irbesartan, 2007
- Figure 30: SWOT analysis: aliskiren
- Figure 31: Datamonitor' s forecast for aliskiren in chronic heart
failure across the seven major markets, 2007-2016
- Figure 32: Datamonitor' s competitive positioning analysis of
Aliskiren, 2007
- Figure 33: SWOT analysis: rosuvastatin
- Figure 34: Datamonitor' s forecast for rosuvastatin in chronic heart
failure across the seven major markets, 2007-2016
- Figure 35: Datamonitor' s competitive positioning analysis of
Rosuvastatin, 2007
- Figure 36: SWOT analysis: Celacade
- Figure 37: Datamonitor' s forecast for VAS-991 in chronic heart failure
across the seven major markets, 2007-2016
- Figure 38: Datamonitor' s competitive positioning analysis of VAS-991,
2007-2016
- Figure 39: Datamonitor drug assessment summary of pipeline molecular
targeted therapies in development for hematological malignancies, 2007
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